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The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.
The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| somofilcon A (habitual) lens, then fanfilcon A (test) lens | Experimental | Participants are habitual wearers of somofilcon A lens and refitted with fanfilcon A lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somofilcon A contact lens | Device | Contact Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Centration for Somofilcon A (Habitual) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline |
| Lens Centration for Somofilcon A (Habitual) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4- weeks |
| Lens Centration for Fanfilcon A (Test) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline |
| Lens Centration for Fanfilcon A (Test) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 2-weeks |
| Lens Centration for Fanfilcon A (Test) Lens | Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4- weeks |
| Lens Corneal Coverage for Somofilcon A (Habitual) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Baseline |
| Lens Corneal Coverage for Somofilcon A (Habitual) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Wearing Time - Somofilcon A (Habitual) Lens | Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day | 4-weeks |
| Average Daily Wearing Time - Fanfilcon A (Test) Lens |
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Inclusion Criteria:
Exclusion Criteria:
Has a CL prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder of ≥ 1.00D in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
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| Name | Affiliation | Role |
|---|---|---|
| Ruben Velázquez Guerrero, MSc., FIACLE | School of Optometry, National Autonomous University (UNAM), Mexico City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic, National Autonomous University | Mexico City | 54090 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Somofilcon A (Habitual) Lens, Then Fanfilcon A (Test) Lens | Participants wore somofilcon A lens (habitual) for 4- weeks and refitted with fanfilcon A lens (test) for 4-weeks. somofilcon A contact lens: Contact Lens fanfilcon A contact lens: Contact Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Participants wore somofilcon A lens (habitual) for 4- weeks and refitted with fanfilcon A lens (test) for 4-weeks. somofilcon A contact lens: Contact Lens fanfilcon A contact lens: Contact Lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lens Centration for Somofilcon A (Habitual) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | Baseline |
|
|
From dispense up to 4-weeks for each study lens
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Somofilcon A (Habitual) Lens | Subjects wore their habitual somofilcon A lens for 4 -weeks. somofilcon A contact lens: Contact Lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D, MSc., FAAO | CooperVision. Inc | 9256213761 | javega@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2019 | Jul 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.
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Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses.
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| fanfilcon A contact lens | Device | Contact Lens |
|
|
| 4 -weeks |
| Lens Corneal Coverage for Fanfilcon A (Test) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Baseline |
| Lens Corneal Coverage for Fanfilcon A (Test) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 2-weeks |
| Lens Corneal Coverage for Fanfilcon A (Test) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 4-weeks |
| Percentage of Lens Tightness for Somofilcon A (Habitual) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | Baseline |
| Percentage of Lens Tightness for Somofilcon A (Habitual) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | 4-Weeks |
| Percentage of Lens Tightness for Fanfilcon A (Test) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | Baseline |
| Percentage of Lens Tightness for Fanfilcon A (Test) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | 2-Weeks |
| Percentage of Lens Tightness for Fanfilcon A (Test) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | 4-Weeks |
| Post-Blink Movement for Somofilcon A (Habitual) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | Baseline |
| Post-Blink Movement for Somofilcon A (Habitual) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | 4-weeks |
| Post-Blink Movement for Fanfilcon A (Test) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | Baseline |
| Post-Blink Movement for Fanfilcon A (Test) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | 2-weeks |
| Post-Blink Movement for Fanfilcon A (Test) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | 4-weeks |
| Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | Baseline |
| Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | 4-weeks |
| Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | Baseline |
| Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | 2-weeks |
| Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | 4-weeks |
Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
| 2-weeks |
| Average Daily Wearing Time - Fanfilcon A (Test) Lens | Average daily wearing time for fanfilcon A (test) lens was measured in hours/day | 4-weeks |
| Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens | Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation. | 4 weeks |
| Average Comfortable Wearing Time - Fanfilcon A (Test) Lens | Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation. | 2 weeks |
| Average Comfortable Wearing Time - Fanfilcon A (Test) Lens | Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation. | 4 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Lens Centration for Somofilcon A (Habitual) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | 4- weeks |
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| Primary | Lens Centration for Fanfilcon A (Test) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | Baseline |
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| Primary | Lens Centration for Fanfilcon A (Test) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | 2-weeks |
|
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| Primary | Lens Centration for Fanfilcon A (Test) Lens | Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | 4- weeks |
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| Primary | Lens Corneal Coverage for Somofilcon A (Habitual) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of participants | Baseline |
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| Primary | Lens Corneal Coverage for Somofilcon A (Habitual) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of participants | 4 -weeks |
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| Primary | Lens Corneal Coverage for Fanfilcon A (Test) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of participants | Baseline |
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| Primary | Lens Corneal Coverage for Fanfilcon A (Test) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of participants | 2-weeks |
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| Primary | Lens Corneal Coverage for Fanfilcon A (Test) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of participants | 4-weeks |
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| Primary | Percentage of Lens Tightness for Somofilcon A (Habitual) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Percentage of Lens Tightness for Somofilcon A (Habitual) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | Posted | Mean | Standard Deviation | units on a scale | 4-Weeks |
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| Primary | Percentage of Lens Tightness for Fanfilcon A (Test) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Percentage of Lens Tightness for Fanfilcon A (Test) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | Posted | Mean | Standard Deviation | units on a scale | 2-Weeks |
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| Primary | Percentage of Lens Tightness for Fanfilcon A (Test) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | Posted | Mean | Standard Deviation | units on a scale | 4-Weeks |
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| Primary | Post-Blink Movement for Somofilcon A (Habitual) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Post-Blink Movement for Somofilcon A (Habitual) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
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| Primary | Post-Blink Movement for Fanfilcon A (Test) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Post-Blink Movement for Fanfilcon A (Test) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
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| Primary | Post-Blink Movement for Fanfilcon A (Test) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
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| Primary | Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
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| Primary | Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
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| Primary | Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
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| Secondary | Average Daily Wearing Time - Somofilcon A (Habitual) Lens | Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day | Posted | Mean | Standard Deviation | hours/day | 4-weeks |
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| Secondary | Average Daily Wearing Time - Fanfilcon A (Test) Lens | Average daily wearing time for fanfilcon A (test) lens was measured in hours/day | Posted | Mean | Standard Deviation | hours/day | 2-weeks |
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| Secondary | Average Daily Wearing Time - Fanfilcon A (Test) Lens | Average daily wearing time for fanfilcon A (test) lens was measured in hours/day | Posted | Mean | Standard Deviation | hours/day | 4-weeks |
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| Secondary | Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens | Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation. | Posted | Mean | Standard Deviation | hours/day | 4 weeks |
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| Secondary | Average Comfortable Wearing Time - Fanfilcon A (Test) Lens | Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation. | Posted | Mean | Standard Deviation | hours/day | 2 weeks |
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| Secondary | Average Comfortable Wearing Time - Fanfilcon A (Test) Lens | Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation. | Posted | Mean | Standard Deviation | hours/day | 4 weeks |
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| 0 |
| 41 |
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| 41 |
| 0 |
| 41 |
| EG001 | Fanfilcon A (Test) Lens | Subjects were refitted with fanfilcon A lens (test) for 4- weeks. fanfilcon A contact lens: Contact Lens | 0 | 41 | 0 | 41 | 0 | 41 |
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